APPLICATION
NDA050586
TYPE
NDA
ORIGINAL APPROVAL
1988-06-10
LATEST ACTION
2018-06-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
PRED-G · ReferenceDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE, PREDNISOLONE ACETATE 1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2002-04-12Manufacturing (CMC) · Supplement 24 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 23 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 21 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 20 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 19 · standardAP
1999-04-26Manufacturing (CMC) · Supplement 18 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 17 · standardAP
1997-10-01Manufacturing (CMC) · Supplement 16 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 15 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 14 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 10 · standardAP
1991-12-30Labeling · Supplement 13AP
1989-04-21Efficacy · Supplement 5AP
1988-11-30Labeling · Supplement 1AP
1988-10-31Manufacturing (CMC) · Supplement 7 · standardAP
1988-07-29Manufacturing (CMC) · Supplement 4 · standardAP
1988-07-29Manufacturing (CMC) · Supplement 2 · standardAP
1988-06-10Type 4 - New Combination · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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